Understanding the Burden of ACC Through the Eyes of Patients

Adenoid Cystic Carcinoma Clinical Trial

Official title:

Understanding the Burden of ACC Through the Eyes of Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04706845
• Other study ID #: AL Patient Burden 01
• Status: Completed
• Start date: January 11, 2021
• Est. completion date: August 16, 2023

Study information

• Verified date: September 2023
• Source: Ayala Pharmaceuticals, Inc,
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.

Primary Objectives:

• To identify the specific burdens faced by patients with ACC

• To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)

Description:

This is a comprehensive, cross-sectional study conducted with approximately 40-60 individuals affected by ACC who may know the results of molecular profiling of their tumor.

Primary Objectives:

• To identify the specific burdens faced by patients with ACC

• To compare/contrast the burdens faced by patients with ACC at different disease stages (no evident disease, metastatic disease/watchful waiting, progressive disease)

Secondary Objectives:

• To assess QoL implication in patients living with ACC (Adenoid Cystic Carcinoma)

• To compare the burdens and QoL impacts in people living with ACC, with their tumors bearing Notch mutations or Notch Wild Type due to:

• Rate of disease progression

• Location of Metastases

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Participant must be a person diagnosed with ACC who is 18 years or older

2. For patients with metastatic disease; watchful waiting or progressive disease, participants must know the results of molecular profiling of their tumor

3. Histologically-confirmed diagnosis of ACC with written proof of disease and molecular profile of tumor provided. This can be a note showing genetic diagnosis from a relevant testing laboratory, physician consult notes, a medical record of diagnosis, or any other single piece of documentation that connects your name/the patient's name with ACC.

4. Able to read, write and understand English, Hebrew, Arabic, or Russian

5. Able to grant informed consent

6. Willing to participate in a 45-to-60-minute telephone interview, including follow up questions (if necessary)

Exclusion Criteria:

1. Inability to meet any of the inclusion criteria

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma, Adenoid Cystic

Locations

Country	Name	City	State
United States	Engage Health	Eagan	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
Ayala Pharmaceuticals, Inc,	Adenoid Cystic Carcinoma Research Foundation, Engage Health Inc., Hadassah Medical Organization, Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Key burdens related to the disease or treatments		Q4-2021
Primary	Life impacts of those burdens for patient/family		Q4-2021